Cooperative Adenomyosis Network

Infertility, Female Clinical Trial

— CAN  

Official title:

A Study of Cooperative Network of Diagnosis and Treatment of Uterine Adenomyosis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03230994
• Other study ID #: CAN201706
• Status: Recruiting
• Start date: June 30, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: November 2018
• Source: Peking Union Medical College Hospital
• Contact: Lei L Li, MD
• Phone: 139-1198-8831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To set up a Cooperative Network by enrolling 5000 patients with Adenomyosis(AM) from multiple centers.Based on the Network platform and Database,the investigators try to explore the diagnostic strategies for AM and carry out epidemiological survey on the semeiology of AM.In addiction，the investigators expect to conduct research on the effect and the follow-up fertility outcomes of different medical or surgical treatment, the etiology of AM and endometriosis,the perspective investigation of the malignant transformation of AM ;the high-risk factors of AM,and finally propel the formation of Expert Consensus and Clinical Guidelines about AM which suitable to chinese conditions.

Description:

5000 women diagnosed of Adenomyosis(AM) with pathology, transvaginal ultrasonography or magnetic resonance image（MRI）will be enrolled from nationwide multicenters. The investigators would build up Network platform, and database with the registered data within 6 months. 30-month follow-up with an interval of at least once every 6 months will be done for every patient ，and update the database timely.

Based on the Network platform and Database,we try to explore the diagnostic strategies for AM and carry out epidemiological survey on the semeiology of AM.In addiction，the investigators expect to conduct research on the effect and the follow-up fertility outcomes of different medical or surgical treatment,the etiology of AM and endometriosis,the perspective investigation of the malignant transformation of AM ;the high-risk factors of AM,and finally propel the formation of Expert Consensus and Clinical Guidelines about AM which suitable to chinese conditions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 30, 2020
• Est. primary completion date: June 30, 2020
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Women diagnosed of adenomyosis by pathology, transvaginal ultrasound or MRI.

Exclusion Criteria:

• Refusal to join the study

Related Conditions & MeSH terms

• Adenomyosis
• Dysmenorrhea
• Infertility
• Infertility, Female
• Metrorrhagia
• Pathology
• Radiography
• Ultrasonography

Locations

Country	Name	City	State
China	Lei Li	Beijing	China/Beiing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Alabiso G, Alio L, Arena S, Barbasetti di Prun A, Bergamini V, Berlanda N, Busacca M, Candiani M, Centini G, Di Cello A, Exacoustos C, Fedele L, Fuggetta E, Gabbi L, Geraci E, Imperiale L, Lavarini E, Incandela D, Lazzeri L, Luisi S, Maiorana A, Maneschi F, Mannini L, Mattei A, Muzii L, Pagliardini L, Perandini A, Perelli F, Pinzauti S, Porpora MG, Remorgida V, Leone Roberti Maggiore U, Seracchioli R, Solima E, Somigliana E, Tosti C, Venturella R, Vercellini P, Viganò P, Vignali M, Zannoni L, Zullo F, Zupi E; Endometriosis Treatment Italian Club. Adenomyosis: What the Patient Needs. J Minim Invasive Gynecol. 2016 May-Jun;23(4):476-88. doi: 10.1016/j.jmig.2015.12.017. Epub 2016 Jan 6. Review. — View Citation

Levy G, Dehaene A, Laurent N, Lernout M, Collinet P, Lucot JP, Lions C, Poncelet E. An update on adenomyosis. Diagn Interv Imaging. 2013 Jan;94(1):3-25. doi: 10.1016/j.diii.2012.10.012. Epub 2012 Dec 12. Review. — View Citation

Li L, Leng JH, Shi JH, Zhang JJ, Jia SZ, Li XY, Dai Y, Zhang JR, Li T, Xu XX, Liu ZZ, You SS, Chang XY, Lang JH. [A prospective study on the effects of levonorgestrel-releasing intrauterine system for adenomyosis with menorrhagia]. Zhonghua Fu Chan Ke Za — View Citation

Pontis A, D'Alterio MN, Pirarba S, de Angelis C, Tinelli R, Angioni S. Adenomyosis: a systematic review of medical treatment. Gynecol Endocrinol. 2016 Sep;32(9):696-700. Epub 2016 Jul 5. Review. — View Citation

Sakhel K, Abuhamad A. Sonography of adenomyosis. J Ultrasound Med. 2012 May;31(5):805-8. Review. — View Citation

Struble J, Reid S, Bedaiwy MA. Adenomyosis: A Clinical Review of a Challenging Gynecologic Condition. J Minim Invasive Gynecol. 2016 Feb 1;23(2):164-85. doi: 10.1016/j.jmig.2015.09.018. Epub 2015 Sep 30. Review. — View Citation

Vercellini P, Consonni D, Barbara G, Buggio L, Frattaruolo MP, Somigliana E. Adenomyosis and reproductive performance after surgery for rectovaginal and colorectal endometriosis: a systematic review and meta-analysis. Reprod Biomed Online. 2014 Jun;28(6): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic effect and Diagnostics	Symptom Assessment	2day
Secondary	Pathology	Diagnostic assessment	1day
Secondary	selection of therapeutic scheme	pharmacotherapy or surgery	1day
Secondary	vision algetic standard(VAS)	Semeiology and evaluative criteria	2day
Secondary	B type ultrasound	Diagnostic assessment	1day
Secondary	Magnetic Resonance Imaging	Diagnostic assessment	1day
Secondary	pictorial blood loss assessment chart(PBAC)	Semeiology and evaluative criteria	2day

External Links

•   Clinical Challenge
•   Fertility Outcome
•   ING-IUS
•   Medical Treatment
•   MRI
•   Transvaginal Sonography
•   Treatment Choices